Safety reporting quality in multiple sclerosis clinical trials: A review of phase III clinical trials included in FDA approval of disease-modifying treatments

TL;DR

This paper reviews safety reporting in clinical trials for multiple sclerosis treatments and finds that while it has improved over time, there are still gaps in reporting quality.

Contribution

The study evaluates safety reporting quality in MS clinical trials using CONSORT guidelines and identifies factors associated with better reporting.

Findings

Safety reporting quality in MS trials was fair, with an average score of 10.2 out of 15.

Trials with small molecule interventions and recent publications showed higher quality reporting.

Laboratory-defined toxicity and adverse event definitions were notably underreported.

Abstract

Evaluating safety of emerging interventions is important in clinical trials. To support reporting of safety outcomes, a harms extension of the Consolidated Standards of Reporting Trial (CONSORT) guidelines was published in 2004.

To examine safety reporting in pivotal trials of disease-modifying therapies (DMTs) in patients with multiple sclerosis (MS).

Published phase III clinical trials from 1995 to 2022 included in FDA approval material for MS DMTs were compiled and reviewed by two independent examiners. Criteria derived from the CONSORT harms extension were used to evaluate safety reporting. Linear regression was applied to examine associations between quality of safety reporting and study level factors.

30 publications were included in the analysis. Overall, safety reporting quality was fair with an average score of 10.2 out of 15. Trials examining small molecule versus biologic interventions (p = 0.001) and recent publication (p = 0.005) were associated with higher quality reporting. Items related to laboratory-defined toxicity and defining adverse events were among reporting items notably lacking (present in 53% and 40% of publications, respectively).

While the reporting of phase III clinical trials for DMTs for the treatment of MS has improved with time, there remain gaps and opportunities for further improvement.

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